p-value | |||||||||
---|---|---|---|---|---|---|---|---|---|
Preferred term | PBO N = 295 n (%) | LY40 N = 292 n (%) | LY80 N = 280 n (%) | RIS N = 142 n (%) | Total N = 1009 n (%) | Overall | LY40 vs. PBO | LY80 vs. PBO | RIS vs. PBO |
Patients with > = 1 TEAE | 177 (60.0) | 159 (54.5) | 176 (62.9) | 82 (57.7) | 594 (58.9) | 0.220 | 0.183 | 0.494 | 0.678 |
Headache | 27 (9.2) | 20 (6.8) | 21 (7.5) | 11 (7.7) | 79 (7.8) | 0.770 | 0.362 | 0.547 | 0.719 |
Schizophrenia | 23 (7.8) | 14 (4.8) | 16 (5.7) | 5 (3.5) | 58 (5.7) | 0.284 | 0.174 | 0.407 | 0.098 |
Nausea | 14 (4.7) | 22 (7.5) | 16 (5.7) | 5 (3.5) | 57 (5.6) | 0.338 | 0.172 | 0.708 | 0.627 |
Insomnia | 21 (7.1) | 10 (3.4) | 15 (5.4) | 10 (7.0) | 56 (5.6) | 0.188 | 0.064 | 0.396 | >.999 |
Blood CK increased | 15 (5.1) | 12 (4.1) | 17 (6.1) | 4 (2.8) | 48 (4.8) | 0.485 | 0.694 | 0.717 | 0.327 |
Anxiety | 9 (3.1) | 11 (3.8) | 12 (4.3) | 5 (3.5) | 37 (3.7) | 0.887 | 0.657 | 0.508 | 0.778 |
Vomiting | 6 (2.0) | 11 (3.8) | 13 (4.6) | 5 (3.5) | 35 (3.5) | 0.350 | 0.229 | 0.102 | 0.347 |
Dyspepsia | 5 (1.7) | 7 (2.4) | 11 (3.9) | 8 (5.6) | 31 (3.1) | 0.105 | 0.575 | 0.130 | 0.033* |
Constipation | 8 (2.7) | 7 (2.4) | 7 (2.5) | 5 (3.5) | 27 (2.7) | 0.900 | >.999 | >.999 | 0.765 |
Psychotic disorder | 7 (2.4) | 6 (2.1) | 10 (3.6) | 2 (1.4) | 25 (2.5) | 0.594 | >.999 | 0.465 | 0.724 |
Agitation | 3 (1.0) | 8 (2.7) | 10 (3.6) | 1 (0.7) | 22 (2.2) | 0.102 | 0.141 | 0.050* | >.999 |
Weight increased | 2 (0.7) | 4 (1.4) | 1 (0.4) | 5 (3.5) | 12 (1.2) | 0.049* | 0.449 | >.999 | 0.039* |
Restlessness | 5 (1.7) | 1 (0.3) | 0 (0.0) | 4 (2.8) | 10 (1.0) | 0.008* | 0.216 | 0.062 | 0.481 |
Extrapyramidal disorder | 3 (1.0) | 0 (0.0) | 6 (2.1) | 0 (0.0) | 9 (0.9) | 0.029* | 0.249 | 0.329 | 0.554 |
Dysmenorrhoea | 0 (0.0 | 5 (5.2) | 0 (0.0) | 1 (1.8) | 6 (1.7) | 0.006* | 0.019* | 0.325 | |
Sinusitis | 0 (0.0) | 5 (1.7) | 0 (0.0) | 1 (0.7) | 6 (0.6) | 0.013* | 0.030* | 0.325 | |
Asthenia | 2 (0.7) | 0 (0.0) | 0 (0.0) | 4 (2.8) | 6 (0.6) | 0.002* | 0.499 | 0.499 | 0.091 |
Fatigue | 1 (0.3) | 0 (0.0) | 1 (0.4) | 3 (2.1) | 5 (0.5) | 0.031* | >.999 | >.999 | 0.103 |
Hyperhidrosis | 0 (0.0) | 0 (0.0) | 1 (0.4) | 2 (1.4) | 3 (0.3) | 0.019* | 0.487 | 0.105 |